FDA Enforcement
Class II
Ongoing
Chromophare Surgical Light System , REF CH00000001
Recall: Z-1506-2024
·
Reported April 17, 2024
Enforcement
- Recall Number
- Z-1506-2024
- Event ID
- 94199
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Communications
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2024
- Initiation Date
- February 8, 2024
- Classification Date
- April 9, 2024
- Address
- 571 Silveron Blvd, N/A, Flower Mound, TX, 75028, United States
Description
Chromophare Surgical Light System , REF CH00000001
Reason
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Code Info
S/N:03857056/ UDI: 07613327296167
Distribution
US: None OUS: Chili
Quantity
1 unit